Ignite Creation Date:
2024-05-06 @ 3:20 PM
Last Modification Date:
2024-10-26 @ 1:48 PM
Study NCT ID:
NCT04606186
Status:
UNKNOWN
Last Update Posted:
2022-05-18
First Post:
2020-09-09
Brief Title:
Influence of Probiotics on Clinical Parameters the Oral Microbiome and the Immune System During an Orthodontic Treatment in Adult Patients
Sponsor:
University of Erlangen-Nürnberg
Organization:
University of Erlangen-Nürnberg
Study Overview
Official Title:
Influence of Probiotics on Clinical Parameters the Oral Microbiome and the Immune System During an Orthodontic Treatment in Adult Patients a Prospective Double-blind Randomized Clinical Study
Status:
UNKNOWN
Status Verified Date:
2022-05
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Orthodontic treatment with fixed appliances can be necessary to correct malocclusions in adolescence or adulthood It its known that orthodontic treatment induces aseptic pseudo-inflammatory reactions However studies could show that an increase of certain inflammatory cytokines during orthodontic treatment correlated with a higher risk of root resorption Moreover it has been shown that orthodontic treatment leads to a dysbiosis of the oral microbiome especially during the first 3 months of the orthodontic treatment This could be a potential risk factor as the inflammation of periodontitis during an orthodontic treatment could favor root resorption and progressive destruction of the periodontal apparatus
Probiotics are already used successfully as an adjuvant therapy in the treatment of periodontitis to improve clinical parameters and to reduce local inflammation However there are only a few studies that investigated the influence of probiotics during an orthodontic treatment
Therefore the aim of our study is to investigate if the daily intake of lozenges containing probiotics versus placebo lozenges during the first 3 months of orthodontic treatment with fixed appliances can improve clinical parameters reduce local inflammation systemic inflammation and prevent a dysbiosis of the oral microbiome
Probiotics are already used successfully as an adjuvant therapy in the treatment of periodontitis to improve clinical parameters and to reduce local inflammation However there are only a few studies that investigated the influence of probiotics during an orthodontic treatment
Therefore the aim of our study is to investigate if the daily intake of lozenges containing probiotics versus placebo lozenges during the first 3 months of orthodontic treatment with fixed appliances can improve clinical parameters reduce local inflammation systemic inflammation and prevent a dysbiosis of the oral microbiome
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None